Nutritional Interventions for Type 2 Diabetes

(KP ENRICH Trial)

Recruiting at 1 trial location

Overseen By Richard Grant, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kaiser Permanente

Disqualifiers: Advanced kidney disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 6 months

1100 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on dietary changes rather than medication adjustments.

What data supports the effectiveness of the treatment Financial support for healthy foods and free home delivery for Type 2 Diabetes?

Research shows that programs providing fresh produce and nutrition education can improve diet quality and health outcomes, such as better blood sugar control, in people with diabetes. These programs, like the Produce Rx program, have been successful in increasing fruit and vegetable consumption and improving attitudes towards healthy eating. ^{1 2 3 4 5}

Is the Nutritional Intervention for Type 2 Diabetes safe for humans?

The studies on food prescription and delivery programs, like those for diabetes patients, show they are generally safe and well-received, with high participant satisfaction and improved food security. No specific safety concerns were reported in these studies. ^{2 6 7 8 9}

How is the treatment of financial support for healthy foods and free home delivery unique for type 2 diabetes?

This treatment is unique because it combines financial support for healthy foods with free home delivery, specifically targeting food insecurity and promoting better nutrition among patients with type 2 diabetes. Unlike traditional treatments that focus on medication, this approach addresses social determinants of health by ensuring access to nutritious food, which can improve overall health and potentially reduce health disparities. ^{2 3 7 9 10}

What is the purpose of this trial?

The goal of this randomized controlled trial is to compare the effect of receiving 6 months of monetary support for healthy food through a food delivery platform on change in glycosylated hemoglobin (HbA1c) levels among adults with type 2 diabetes mellitus with glycemic control that is above target level. The main study aims are to: 1. To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces glycosylated hemoglobin levels within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control. 2. To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces medical resource utilization within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.

Research Team

Claudia L Nau, PhD

Principal Investigator

Kaiser Permanente

Richard Grant, MD, MPH

Principal Investigator

Kaiser Permanente

Eligibility Criteria

This trial is for adults over 18 with Type 2 diabetes, poor glycemic control (HbA1c ≥7.5%), and Medi-Cal insurance through Kaiser Permanente. Participants need internet access and can't have other private insurance, advanced kidney disease, be on dialysis or post-kidney transplant, or be pregnant.

Inclusion Criteria

Current access to the internet via computer or mobile device

No interpreter needed

I am a Kaiser Permanente member with only Medi-Cal insurance.

Exclusion Criteria

Known pregnancy at time of identification

My kidney function is very low, I'm on dialysis, or I've had a kidney transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of monetary support for healthy food or free delivery through the Instacart platform

6 months

Monthly assessments

Follow-up

Participants are monitored for changes in glycosylated hemoglobin levels and other health outcomes

6 months

Assessments at 6 and 12 months

Long-term follow-up

Participants' medical resource utilization and other outcomes are evaluated

12 months

Assessments at 3, 6, and 12 months

Treatment Details

Interventions

• Financial support for healthy foods and free home delivery
• Free home delivery

Trial Overview The study tests if financial support for healthy food delivery affects blood sugar control in high-risk diabetic patients better than just free delivery. It's a randomized trial comparing two groups: one gets money towards healthy foods plus delivery; the other only gets the delivery service.

Participant Groups

Group I: Free Delivery Experimental Treatment 1 Intervention

The control group will receive only free home delivery through the Instacart platform.

Group II: Financial Support and Free Delivery Experimental Treatment 1 Intervention

The intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform.

Financial support for healthy foods and free home delivery is already approved in United States for the following indications:

Approved in United States as Financial Support for Healthy Foods and Free Home Delivery for:

• Type 2 Diabetes Mellitus with Suboptimal Glycemic Control

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Findings from Research

A pilot food prescription program called Fresh Start Food Rx provided biweekly fresh fruits and vegetables and dietary education to four uninsured patients in South Miami, showing potential to improve dietary behaviors and attitudes toward healthy eating.

Participants reported an increase in the number of days they consumed fruits per week and a rise in vegetable servings, indicating that access to healthy foods and education can positively influence eating habits and perceptions about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. Oliveira, JB., To, L., De La Cruz, Y., et al.[2021]

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.

Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. Forbes, JM., Forbes, CR., Lehman, E., et al.[2020]

A clinic-based intervention that included food insecurity screening and nutrition education led to a significant decrease in HbA1c levels among patients with diabetes, indicating improved glycemic control.

Food secure participants showed greater improvements in HbA1c compared to food insecure participants, suggesting that additional support may be needed for those facing food insecurity to achieve similar health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foods for Health: An Integrated Social Medical Approach to Food Insecurity Among Patients With Diabetes. Blitstein, JL., Lazar, D., Gregory, K., et al.[2022]

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

A prescription (PRx) program in rural Eastern North Carolina provided patients with type 2 diabetes weekly home deliveries of fruits and vegetables, leading to high patient satisfaction and increased consumption of produce.

The program not only improved dietary habits but also significantly enhanced glycemic control, demonstrating the effectiveness of combining food access with nutrition education and culinary resources for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of the Delivery-Based HEALED Produce Rx Program for Uninsured Patients With Diabetes in Rural Eastern North Carolina. Sastre, LR., Stroud, B., Smith, E., et al.[2023]

The Complete Eats Rx program significantly improved food security and diet quality among SNAP participants by incentivizing the purchase of fruits and vegetables, as reported by 26 participants in qualitative sessions.

Barriers to the program's effectiveness included limited supermarket options for redeeming incentives and challenges related to the cost and accessibility of healthy foods, suggesting that expanding partnerships with more local grocers and improving the shopping experience could enhance program usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Study on Participant Perceptions of a Supermarket Fruit and Vegetable Incentive Program. Riemer, S., Walkinshaw, LP., Auvinen, A., et al.[2023]

The Food Rx program, a collaborative initiative involving a university, Walgreens, and local health centers, aims to improve healthy eating among diabetes patients in underserved communities by providing food prescriptions that promote behavior change and connect patients to local resources.

Preliminary implementation results suggest that Food Rx effectively integrates community resources into healthcare settings, showing potential as a model for supporting the health of underserved patients, although it is still in the early stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. Goddu, AP., Roberson, TS., Raffel, KE., et al.[2018]

The study identified key facilitators for the success of Fruit and Vegetable Prescription (FVRx) Programs in Georgia, including the importance of accessible programming and dedicated providers, which can enhance participation among vulnerable patients.

Barriers such as participants' challenging life circumstances and concerns about program sustainability were also highlighted, indicating that future program designs should address these issues to improve effectiveness and longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies and Challenges: Qualitative Lessons Learned From Georgia Produce Prescription Programs. Newman, T., Lee, JS.[2022]

A pilot study involving adults with type 2 diabetes and food insecurity showed that a collaboration between a food bank and a health system to deliver tailored food was feasible and led to high participant satisfaction over 24 weeks.

While the intervention improved food security and overall health status, it did not significantly change HbA1c levels or healthcare utilization, suggesting that while food support is beneficial, additional strategies may be needed to improve glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Collaborative Pilot to Support Patients With Diabetes Through Tailored Food Box Home Delivery. Kempainen, S., Cutts, DB., Robinson-O'Brien, R., et al.[2023]

Participants in a medically-tailored meal program for individuals with type 2 diabetes reported high satisfaction and noted improvements in their quality of life and diabetes management, highlighting the program's effectiveness.

The study emphasized the importance of culturally appropriate meals and suggested that combining these meal programs with diabetes education could enhance their impact on managing diabetes and reducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. Berkowitz, SA., Shahid, NN., Terranova, J., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Foods for Health: An Integrated Social Medical Approach to Food Insecurity Among Patients With Diabetes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Development and Evaluation of the Delivery-Based HEALED Produce Rx Program for Uninsured Patients With Diabetes in Rural Eastern North Carolina. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Qualitative Study on Participant Perceptions of a Supermarket Fruit and Vegetable Incentive Program. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Strategies and Challenges: Qualitative Lessons Learned From Georgia Produce Prescription Programs. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Collaborative Pilot to Support Patients With Diabetes Through Tailored Food Box Home Delivery. [2023]

10. England pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. [2020]